ElectroMagnetic-guided Interstitial Catheter Navigation for Gynecological brachyTherapy
E-MINT
1 other identifier
interventional
10
1 country
1
Brief Summary
Phase I study evaluating the feasibility of using electromagnetic navigation (EMN) for the catheter implantation procedure required of cervical brachytherapy. The addition of EMN to the current HDR brachytherapy workflow has the potential to dramatically improve implant quality and efficiency for the gynecological interstitial brachytherapy program. Implant quality has been reported to be an important predictive factor for local control and late toxicity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedMarch 17, 2020
March 1, 2020
1 year
November 26, 2018
March 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Plan Target Volume and Organs at Risk Dosimetry
The treatment plans generated during the course of treatment for participants will be evaluated. The evaluation of the treatment plans will use the dose received by specific target structures and the dose received by structures that are defined as organs at risk. The specific metric that will be used represents how much dose is received by a certain percentage of a volume. For example, the D98 GTV refers to how much dose is received by 98 percent of the gross tumour volume. The dose is a value that is measured in the unit, Gray. In addition to the dose constraint for the D98 GTV the other dose constraints that will be used for evaluation purposes are, D90 HR-CTV, D98 HR-CTV, D98 IR-CTV and OAR constraints. A significance level of 5% will be used to identify differences between the dose constraints for treatment plans that are generated when EMN is used and when EMN is not used.
14 days
Study Arms (2)
Fraction 1-Addition of EMN
EXPERIMENTALDuring the fraction 1 insertion, the custom MRI-compatible vaginal cylinder will be placed in the patient, and will contain the 6 degree-of-freedom (DOF) sensor. The electromagnetic navigation system and computer will have been setup in the operating room (OR) prior to the procedure and will be used to actively insert up to 25 catheters into the target. The catheters will be inserted using a custom metallic stylet that has a custom 5-DOF sensor embedded in the tip for tracking its position in real-time. The physician may use ultrasound for assistance in target visualization as well. Catheter deflections will be detected and corrected for in real-time by the radiation oncologist as the catheter is inserted into the patient during the procedure, this will occur when the EM system is in use.
Fraction 3-Addition of EMN
EXPERIMENTALFor the second group of patients in the trial the same protocol will be followed as in the first group, the only difference will be that the electromagnetic navigation is used during the second implantation procedure immediately preceding fraction 3 as opposed to fraction 1, the time at which it was used for the first group of patients.
Interventions
Electromagnetic navigation is a form of surgical navigation that can be incorporated into the cervical interstitial brachytherapy workflow to improve the current standards of guidance.
Eligibility Criteria
You may qualify if:
- Women diagnosed with FIGO stage IB2-IVA (locally advanced) cervical cancer being treated with combined 3D interstitial / intracavitary HDR brachytherapy in 4 fractions and concurrent chemotherapy
- Minimum of 2 brachytherapy implantation procedures.
- The Syed-Neblett applicator is indicated for use due to the extent/complexity of the disease
- Given informed consent to take part in the study
You may not qualify if:
- Metastatic disease
- Bilateral or unilateral hip prostheses
- Pacemakers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ananth Ravi, PhD
Sunnybrook Health Sciences Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Operations Lead of Brachytherapy
Study Record Dates
First Submitted
November 26, 2018
First Posted
December 19, 2018
Study Start
October 1, 2019
Primary Completion
October 1, 2020
Study Completion
February 1, 2021
Last Updated
March 17, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available within 6 months of study completion.
- Access Criteria
- Data access requests external to the Odette Cancer Centre will be reviewed by the REB at Sunnybrook Health Science Centre prior to permitting access.
Results will be made available to relevant stakeholders within the Odette Cancer Centre as these results may assist in the translation of this trial into routine clinical practice.